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첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)

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閲覧日 2026年9月20日更新 2026年9月20日
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FactCell Banking: Korea: cell processing facility approval = Cell processing requires MFDS approval as an advanced regenerative medicine cell processing facility, and the licence must be renewed every 3 years (Advanced Regenerative Bio Act, Art. 15).FactCell Processing Facility: Definition = A facility that collects human cells, inspects and processes them, and supplies them to institutions performing advanced regenerative medicineFactCell Processing Facility: Legal basis = Article 15, Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced BiopharmaceuticalsFactCell Processing Facility: Licensing regime in force since = 2020-08-28 (Law No. 16556, enacted 2019-08-27)FactCell Processing Facility: Who may apply for a licence = National or local governments, medical institutions, drug manufacturers, medical device manufacturers, cord blood banks, corporations set up mainly for cell processing, and others named by presidential decreeFactCell Processing Facility: Deemed licence = Holders of a human cell management business licence (Article 28) can notify MFDS and are then treated as licensedFactCell Processing Facility: Record-keeping duty = The facility head must keep cell processing records and report regularly to the Advanced Regenerative Medicine safety management agencyFactCell Processing Facility: Closure or suspension reporting = Report within 7 days. No report is needed for a suspension of less than one month daysAnswer세포처리시설 허가는 어디서 받나요?Answer세포처리시설 허가 현황은 어디서 확인하나요?Answer첨단재생의료실시기관과 세포처리시설의 차이는 무엇인가요?Answer세포처리시설 허가는 몇 년마다 갱신하나요?Answer병원이 직접 세포를 처리해서 첨단재생의료를 할 수 있나요?Answer첨단재생의료란 무엇이며 국내에서는 어떻게 관리되나요?Answer재생의료 시술은 어디에서 받아야 안전한가?Answer셀뱅킹 업체가 허가를 받은 곳인지 어떻게 확인하나요?Answer2025년 2월 시행된 첨단재생의료법 개정으로 셀뱅킹 이용자 입장에서 달라진 점은 무엇인가요?Answer'FDA 등록 시설'이라는 홍보 문구는 승인을 받았다는 뜻인가요?Answer보관료와 해지·환불 조건은 어디서 확인할 수 있나요?Answer지방흡입·지방이식할 때 남은 지방에서 SVF를 뽑아 보관했다가 재수술에 쓰는 것이 가능한가요?Answer韓国のクリニックでセルバンキングを勧められました。韓国では細胞の保管にどんな許可が必要ですか？Answer韓国で脂肪吸引や脂肪注入を受けるとき「2回目のために細胞を保管しましょう」と勧められました。契約前に何を確認すべきですか？Answer海外のバンクが「FDA登録済み」と説明していたら、品質を信用してよいのでしょうか？Answer日本語での説明や日本語の契約書はもらえますか。書面では何を確認すればよいですか？Answer怎么核验一家韩国细胞存储机构是不是有正规资质？Answer存在韩国的细胞，将来能带回中国使用吗？Answer细胞存储费用大概多少？合同里最该盯住哪几条？Answer给孩子存脐带血和给自己存脂肪来源SVF，这两件事有什么区别？Answerسأجري عملية شفط دهون في كوريا وعرضت علي العيادة حفظ خلايا SVF من الدهون المستخلصة. ما الذي أتحقق منه قبل التوقيع؟Answerما التراخيص التي يشترطها النظام الكوري على الجهة التي تحفظ الخلايا؟Answerعيادة تقول إنها مسجلة لدى FDA، هل يعني ذلك أن خدمة الحفظ معتمدة؟Article세포처리시설(Cell Processing Facility): 정의·허가 요건·재생의료기관과의 관계·허가 확인 방법